WP1. Appendix 1: WP1/Exec Comm f-t-f meeting summary, April 18-19, 2012, Rome, Italy

Transcription

1 WP1 Appendix 1: WP1/Exec Comm f-t-f meeting summary, April 18-19, 2012, Rome, Italy

2 EUnetHTA Joint Action WP1/ Exec Comm meeting Rome, Italy April 18, 2012, 13:00 17:30 April 19, 2012, 09:00 15:00 Organised by: AGENAS and the EUnetHTA Secretariat Address of the meeting venue: NH Leonardo da Vinci, Via dei Gracchi, Rome Tel Mobile (Julia Chamova) Summary report Agenda April 18, Opening, practical details 13:00-13:10 2. WP Updates a. Secretariat guidance on planning for Oct-Dec 2012 (JA/JA2 overlap) 3. EUnetHTA and permanent European network on HTA I a. Commission and MS updates on current developments re: Article 15 implementation b. Membership issues c. Levels of involvement d. Stakeholder relations/involvement 13:10 14:00 14:00 17:30 Coffee break 15:15 15:30 Social dinner: Restaurant Taberna de' Gracchi, Via dei Gracchi, :00 April 19, EUnetHTA and permanent European network on HTA II a. Governance, management and accountability b. Financing streams c. Working with EU bodies and international organisations / networks d. Finalising the EUnetHTA Strategy development and moving to implementation 9:00 12:00 Coffee break 10:30 11:00 Lunch 12:00 13:00 2. EUnetHTA Plenary Assembly, Lisbon, May a. Agenda b. Nomination process and elections c. Practicalities 3. Other issues and conclusion a. EUnetHTA at HTAi b. EUnetHTA info platform development (JA and JA2) c. JA budget reallocation update 13:00 13:30 13:30 15:00

3 April 18, 2012 WP Updates Finn Børlum Kristensen (FBK), EUnetHTA Secretariat (NBoH), welcomed the participants to the fifth face-to-face EUnetHTA JA WP1 and Executive Committee meeting and informed that the JA2 grant agreement was signed by the Danish Medicines and Health Authority (former National Board of Health of Denmark) and sent to the EAHC for their final signature. He further presented the meeting s agenda highlighting its focus on preparation for the EUnetHTA Plenary Assembly meeting (clarifying the set-up of a permanent network for HTA under Article 15 of the cross-border health care Directive (Directive 2011/24/EU). FBK made a brief presentation of the current activities in WP1/WP8 (please see Appendix 1, slide 5). AHTAPol, CVZ, HAS, THL confirmed that they received a request from ECORYS for an interview for the ECORYS cost-benefit study regarding the Secretariat for the permanent network for HTA. It was commented that the ECORYS study is based on a number of assumptions and estimates. Anne-Marie Yazbeck, NIPH, introduced herself as a replacement for Eva Turk and informed about the LP plans to organise a meeting in WP2 (preliminary planned for June 2012). Draft agenda for the meeting will be circulated shortly to the WP2 members. All the deliverables of WP2 have been produced and submitted as planned. FBK commented that in case a meeting is to be held it will be beneficial to clarify the October-December 2012 overlap between the JA and JA2 WPs on dissemination. Kristian Lampe, THL, and Marina Cerbo, AGENAS, presented activities in WP4 (Appendix 2). It was agreed that the draft policies being developed by the WP4 Strand A will be reviewed by the Executive Committee prior to undergoing public consultations. Marina Cerbo highlighted the disappointing quality of information on the technologies chosen for the Core HTAs that was provided by the technology developers (ie, only advertising booklets). She also indicated that the collaboration model where 1 organisation is responsible for one domain of the Core model seems to work best. Furthermore, there is a problem with a low response rate on the surveys. Availability of expertise, inadequate resources and a general problem with sharing methodologies were indicated as possible sources for the problem. Daily routine procedures vary from country to country. Level of HTA development in a country also constitutes a factor in an organisation s ability to actively contribute in general across EUnetHTA. It was suggested that - a survey s objectives need to be better explained as well as thorough consideration should be done prior to choosing survey as the format for collecting necessary information - the approach to answering surveys should differ from an approach to conducting a systematic review - clearly indicating if answering the surveys is mandatory or voluntary - mapping availability of expertise for developing the surveys via WP3 annual survey could be helpful Wim Goettsch and Mira Pavlovic presented activities in WP5 (Appendix 3): - the background review will be published as an article in the scientific journal Value in Health - the pilot on rapid Core HTA has been a good experience that allowed to further develop the approach to the rapid assessment based on the HTA Core model (ie, focus on the first 4 domains with a checklist of issues for other domains). New collaboration approach with 1-2 organisations being responsible for 3-4 domains with other organisations as reviewers will be tested to see if time for production can be reduced - there is a problem with recruiting a technology provider to cooperate in the 2 nd pilot four pharmaceuticals were identified and no company agreed to participate. This has implications for the pilots in JA2 - success and failure factors in implementation of the rapid assessments based on the HTA Core Model will be described with participation of the experts with hand-on experience - draft guidelines received a lot of comments both from WP members and SAGs indicating real engagement on the issue

4 - comments received will most likely be divided in the two groups of their immediate relevance for the process and for future reference (eg, JA2) Patrice Chalon, KCE, presented the activities in WP6 (see Appendix 4). Mira Pavlovic, HAS, and Judit Erdos, LBI, presented activities in WP7 (see appendix 5 and 6). It was suggested to have a date of the reports completion in the POP database (eg, another column of information completed and published with a date). Patrice Chalon confirmed that this is a part of the development plan for the POP Database. The electronic version of the POP database has been launched, however, some partners continue to submit information about the reports in Microsoft Excel sheet format which makes it time- and resourceconsuming for POP database managers to transfer this information into the database. Technical solutions for an automatic transfer of info from the Excel sheets are not yet available and seem difficult to provide. Further work is needed on improving the work-flow for all parties involved in the POP Database maintenance and development. It was suggested to investigate an opportunity for an additional financing of early dialogue pilots through the 2013 health programme budget. Julia Chamova, EUnetHTA Secretariat (NBOH) informed about the planning of the JA1 and JA2 overlap period (October-December 2012) (Appendix 1, slide 11). The first draft contributions to the JA2 3-year Work Plan should be delivered to the secretariat in November Wim Goettsch, CVZ, commented that JA2 WP5 LP and Co-LP will discuss the issue of the planning for achieving the 1 st milestone in JA2 WP5 and get back to the Secretariat shortly (as well as the number of pilot assessments developed as 1 st milestone). The Secretariat will clarify with the EAHC the rules with regards of combining meetings of WP5 of JA1 and JA2 1. Action points: - WP2 to clarify the necessity of holding a face-to-face meeting in June - WP5 to clarify the solution for recruiting the technology developer for the 2 nd pilot (possibly via the Stakeholder Forum) - Follow-up on the financing opportunities for early dialogue pilots through the 2013 health programme budget - Secretariat to clarify the rules with the EAHC regarding the possibility of holding JA1 and JA2 meetings simultaneously - CVZ as JA2 WP5 LP to clarify the planning for achieving the 1 st milestone in JA2 WP5 (M3 December 2012) EUnetHTA and permanent European network on HTA I Jerome Boehm, DG SANCO, informed on the current and future process of implementation of the Article 15 of the CBHC Directive (Appendix 7): - the first meeting of the CBHC Committee will take place on Sept 18, 2012, where EUnetHTA should provide an input on the objectives and achievements of the current JA and considerations for the permanent network for HTA in Europe. The 2 nd CBHC Committee meeting will be held on November 28, The Committee will have about one year to clarify the objectives, etc for the Implementing Act - Rules of procedure (rather detailed and complex) are to be developed after the implementing act is in place - The bilateral meetings with the MS has shown various perspectives on the scope of the work for the permanent network - It is important to have an understanding at the MoH level on what EUnetHTA does and for what purpose - The issue of regions within MS: it is necessary to have a national representation and organize cooperation between regions 1 The JA1 WP5 nad JA2 WP5 have different scopes which is to be taken in consideration when planning the content of the meeting especially with the view of combining both.

5 - Comments on the governance issues indicated the importance of these questions, however, with the view that the process should not be over-formalised (ie, the details can be clarified after October 2013, notably after JA2) - The respective MS health attaches and the MS representatives in the CBHC committee are the communication channel with regards to the activities on the implementation of the CBHC directive Key discussion points can be summarized as follows: - The main governance (strategic decision-making) body should have a representation of the MS that ensure effective communication between the governance and production level (eg, having 2 representatives per MS one with tech HTA competence and one from the MoH). Having a political representative in the Network assembly could reduce the production level s independence, but it can also lead to a strong cooperation and synergies; it will be important to regularly inform the members of this body on the activities and results from the production level - Participation at the production level should reflect the HTA organisation at the national level (eg, more than 1 organisation can be nominated with maximum number of nominated organisations) - Clear distinction of the roles and decision making capacities/power of the Network Assembly ( governance level) and the Executive Committee ( production level) should be ensured - It was unanimously agreed that a Network Forum with representation of all the network participating organisations would be necessary to provide an opportunity for regular network-wide scientific discussions and exchange of experience. It can also serve as an advisory body for the Executive Committee that is to have a direct link to the Network Assembly - The composition of the Executive Committee should be decided by elections from the organisations nominated to participate in the permanent European network - Possibly the Network Assembly will have an authority to approve the output of the network (but not the single HTA reports!) - The role of the Commission in the future network will be a provider of services and financing. Possibly a representative of the Commission can co-chair the Network Assembly - Of utmost importance is to clarify what is to be done by the network in order to develop an appropriate governance and management structure that supports these activities and level of involvement Julia Chamova presented the two descriptions of the levels of involvement in the future permanent network (one from the EUnetHTA strategy document, the other from the Commission s presentation during the Gdansk conference) (Appendix 1, slides 16-17). She further presented a new proposal for the levels of involvement Key discussion points can be summarized as follows: - The new suggested set of levels were accepted as a part of the EUnetHTA Strategy for presentation and endorsement at the Plenary Assembly meeting. A small adjustment (ie, removing database of impact assessment from the list of developed EUnetHTA tools) should be made in the Business Model appendix of the strategy - The EUnetHTA tools and services should be matched to every level to have a better understanding of what activities might correspond to which level - level of development of HTA in a country might influence the level of involvement in the network (based on this consideration, clarifications should be made with regards to the minimum requirements for each level of involvement) - Participation in the network can be at different levels for different types of activities (ie, there is no hierarchy in access to various levels) - Confidentiality issues of accessing and sharing information at different levels should be considered - Broad view on the type of input from the partners into the network should be taken - For simplifying the understanding of what lies behind each level the following interpretation was offered: Level one share and exchange HTA information, Level two common practice based on shared standards, Level 3 doing HTA together and using the results at national level individually

6 FBK presented the issue of membership and participation in the current and future activities of EUnetHTA. During the discussion it was agreed that EUnetHTA should continue its policy of inclusiveness based on the availability of expertise and value that the applying organisations bring to EUnetHTA. It was confirmed that the involvement of the organisations other than the Ministry nominated bodies is indispensable in order to have access to a wider pool of expertise and competence in Europe. The mode of involvement of the organisations that apply for the status of an Associate could be via their contribution either to the activities in the WPs (project-based input) or performing general tasks that are not tied to a specific WP or project (task-based input). The Secretariat is to develop a proposal for the criteria for assessing and accepting the applicants to become EUnetHTA associates (including considerations of the financing sources) The Executive Committee agreed that the current applicants from Germany (GBA and Medical Valley University of Erlangen-Nuremberg) will be considered for acceptance as Associates with the start of JA2 in October 2012 (as JA1 is coming to an end). Medical Valley University of Erlangen-Nuremberg will be requested to provide more detailed information on their sources of finance to make an informed decision regarding the issue of independence from private industry interests (a general issue in relation to university and research institutions). Action points: - EUnetHTA to prepare input for the September 18, 2012 meeting of the CBHC Committee - The EUnetHTA Strategy should be adjusted as per the discussions at the meeting on levels of involvement - The current applicants from Germany should be informed about the decision of the Executive Committee - The Secretariat is to develop a proposal for the criteria for assessing and accepting applicants to become EUnetHTA associates (including considerations of the sources of finance) April 19, 2012 EUnetHTA and permanent European network on HTA II Key discussion points: - Access to the Core HTA Online tool and cards are open for all EUnetHTA Partners and Associates. Careful consideration of the level of access should be given to other potential users of the tools with a view of the possible sources of revenue and involvement of the technology developers in the HTA process (eg, technology file submissions based on the structure of the Core HTA model?) - Current ways of engagement with the stakeholders are working well and beneficial (SF and SAGs), however, there is a need to have an additional (albeit not too resource and time consuming) structure/solution for effective communication and appropriate involvement for the pilots. No concrete proposals were made possibly an issue to discuss with the Stakeholder Forum - The technical function of the scientific secretariat for the permanent network could not be placed in the Commission. Cooperation with the Commission in the issues of the stakeholder involvement in the current JA proved to be beneficial and should be considered for further development in the permanent network - The tasks and projects of the future network will provide a basis for the development of a stakeholder involvement practice, however, the principles, approaches and experience gained in the JA is very valuable for being taken forward in the permanent network - The Executive Committee agreed that the increase of the number of seats from 4 to 6 in each of the SF groups (payers, patients, industry and providers) should be proposed. The current principles allow for involvement of the organisations from the national level as well. The increase should be proposed for endorsement to the Plenary Assembly. - A new open call for expression of interest to participate in the Stakeholder Forum of JA2 will be announced at the beginning of JA2 with the aim of having a new Stakeholder forum in place by the start of 2013.

7 - Discussion of the roles of various bodies in the organisational structure of the permanent network: the Network assembly is for the MS participation (1 vote per country, possibly with 1+1 representation (technical+political); strategic, endorsing role, meeting once a year; Network Forum for participation of the network organisations for discussing the key scientific and working process issues and having an advisory role to the Executive Committee. Division of responsibility and functions between the Network Assembly and Network Forum should be straight forward and clear. - Liaising with the respective MS health attachés is important: the money for the network will come for the Health for Growth programme (2014+ which has a 7-year budget period). Efforts are now made to pre-allocate a certain amount for the HTA network s annual budget for a number of budget years (not to go through an annual negotiation procedure) - Establishing a legal entity for the administrative purposes of eg, receiving grants, holding IPR rights should be strongly considered. It should be clarified within the Commission how it fits with the existing rules on establishing and financing the network. - Some work process and scientific decision making will be delegated to the Activity Centers while the Network Forum will discuss the key scientific and working process issues. The types of decisions to be made at the Activity Center level should be thoroughly discussed: decisions with network consequences should be brought up in the Executive Committee. - E-health network rules of procedure can provide valuable insights. DG SANCO will share the document Marina Cerbo, AGENAS, presented the latest developments in the European regulation on medical devices (Appendix 8). It was commented that EUnetHTA can work on the issue of how to communicate the message from European HTA on assessment of medical devices. First input can be in the fall of 2012 from the exercise of the early advice on devices. It was agreed that the regulatory aspects and HTA aspects should be kept separately. With regards to the financing streams, Jerome Boehm informed that the budget will define the scope of work for the permanent network. Efforts are made to secure money on a multiannual basis. Eligibility criteria for financing the activities would be as it is in the joint action. Some specific activities can be financed through other sources (eg, IMI, FP7, etc). Rules of procedure will clarify the sources of income. It was agreed that WP4 and Secretariat will collaborate in preparation of the discussion of the policy for access to the HTA Core Model tools and information. The Executive Committee does not object to the possibility of having fee for service or membership fee as one of the revenue sources for the permanent network. The long-term perspective should be taken when discussing the financing streams. With regards to collaborating with the international networks and European organisations, it was agreed that cooperation with EMA, CIE and DG Research is prioritised and more formal agreements on cooperation should be put in place. The Executive Committee approved the MoU with the INAHTA to be endorsed by the Plenary Assembly. EUnetHTA Plenary Assembly, Lisbon, May JUCH informed about the agenda, nomination process and the practicalities of the Plenary Assembly meeting in Lisbon, May 24-25, Alric Ruether mentioned that due to the JA2 overlap in the last three months of 2012, some of the agencies will change their status in EUnetHTA (eg, will cease to hold or acquire the status of being Lead/Co-Lead Partner) which may affect their eligibility to run for certain positions in the governance structure of EUnetHTA. FBK clarified that JA and JA2 are phases in the development of the same network, EUnetHTA Collaboration, with a stable core partnership, new members can join (be nominated by the MoH) at any time of the year and therefore could not have an opportunity to vote in elections before the next PA meeting. The overlap will affect a couple of organisations which will not justify holding elections before the next Plenary Assembly is held in March They can, however, nominate in the period prior to the Plenary Assembly meeting. No objections were raised to the approach.

8 FBK requested if HAS, THL and CVZ can be approached by CIRS for their project on benefit/risk assessment. It was agreed that CIRS can contact these agencies. Due to lack of time the presentation for the new website development was not made, but the slides are available for information (Appendix 9). They will be discussed in the Task Force on EUnetHTA JA2 websites The meeting was adjourned at 14:30.

9 Participants List Name Organisation Country Marisa Warmuth Judit Erdos LBI-HTA, Ludwig-Boltzman Institute Austria Patrice Chalon KCE, Belgian Health Care Knowledge Centre Belgium Julia Chamova Finn Børlum Kristensen NBoH, National Board of Health Denmark Kristian Lampe THL, National Institute for Health and Welfare Finland FranÇois Meyer Mira Pavlovic HAS, Haute Autorité de Santé France Alric Rüther IQWIG, Institute for Quality and Efficiency in Health Care Germany Marina Cerbo Nicola Vicari Francesca Gillespie AGENA s, Agenzia Nazionale per i Servizi Sanitari Regionali Italy Anna Zawada a.zawada@aotm.gov.pl AHTAPol, Agency for Health Technology Assessment Poland Anne-Marie Yazbeck anne-marie.yazbeck@ivz-rs.si NIPH, National Institute of Public Health of the Republic of Slovenia Rep. of Slovenia

10 Setefilla Luengo Matos AETS-ISC III Spain Wim Goettsch CVZ, Health Care Insurance Board The Netherlands Jerome Boehm European Commission

11 WP1 Appendix 1 for Appendix 1

12 WP1/ Executive Committee Meeting April 18-19, 2012 Rome, Italy EUnetHTA Joint Action

13 Agenda April 18 2

14 Agenda April 19 3

15 WP Updates Brief overview of the activities in WPs: WP1/8 WP2 WP3 WP4 WP5 WP6 WP7 4

16 WP1/WP8 WP1: delivery of the 2 nd interim report end of April 2012 Finalising the JA2 grant agreement (ready for the signature by EAHC); ECORYS interview Planning for JA and JA2 overlap Preparation of the Plenary Assembly meeting (agenda, nomination process, practicalities) Daily coordination activities: e-/meetings (preparation and reporting), contact database update, Members Updates, external enquiries (surveys, public consultations, public news, etc), interacting with the scientific and policy oriented networks/institutions (eg, DG R&I, EMA, IMI, Green Park, Tapestry, AHRQ ) WP8: SF e-/meetings (next SF ftf meeting September 3, Venice, Italy) SAG member lists and confidentiality agreements update EFPIA seminar; planned EFP meeting All deliverables in place 5

17 Executive Committee face to face meeting WP6 Progress report Patrice Chalon , Rome, Italy EUnetHTA Joint Action

18 WP6 overview Meetings Surveys Communicat ion Members only site Single sign on Planned and ongoing projetcs database 2012 M25 M26 M27 M28 M29 M30 M31 M32 M33 M34 M35 M36 Developmen t and testing 1st emeeting ftf meeting preparation 4th ftf 2nd e- meeting Survey 2 preparation Survey 2 Survey 2 analysis Contact database updated Development and testing Communication on regular basis site update Support to adaptation of information about policy 2nd release HTA reports & supplement al materal Information about policy decisions collaboration w ith existing tool (outside EUnetHTA) is evaluated vs development of specific new tool collaboration w ith existing solutions (outside EUnetHTA) is evaluated Development and testing Report and w orkflow delivered Tool released Tools supporting day to day collaboratio n JA2 w ebsites Training and support Development and testing Mailing list server released Development, testing and provision of learning material User support Evaluation and final report Evaluation and preparation of WP final technical report WP Final technical report

19 Details Task Comment 2 nd survey Delayed due to sick leave Contact db POP db release 2 Documents db Information policy decisions Mailing list JA2 Websites Hold on due to possible change of infrastructure Started, release expected to be delayed Not started yet Evaluation started, see JA2 WP2 Community of Practice No started yet See below 8

20 JA2 Websites: Project description Tasks achieved Description Surveys and interviews Requirements synthesised Analysis of requirements Technical options identified for Website and Intranet / workrooms / project management + basic tests Preliminary contacts with potential furnishers (technical information) Tasks to do Meeting task force (planned Apr. 24) Preparation European tender Planning April: meetings task force, preparation tender May: tender June-July: selection provider Oct: Start implementation 01/01/2013: Live 9

21 JA2 Websites: participants KCE Secretariat Gudrun Briat, Patrice Chalon, Carl Devos, Kirsten Holdt Henningsen Julia Chamova, Naomi Dayan, Inge Merete Skov Task Force Susanne Eksell, Gottfried Endel, Judit Erdos, Eleanor Gueguan, Wim Goettsch, Sarah Kleijnen, Leena Raustia, Ingvil Sæterdal, Sorin Stanel, Claudia Wild, 10

22 JA1/JA2 overlap See Gantt chart! (Excel doc) From October 1, 2012 a cost recording system that identifies the costs for JA1 and JA2 SEPARATELY should be in place! The reporting of the activities should also be done separately (time sheets, etc) Sept 2012 Secretariat will inform on the format for JA1 final reporting January 15, 2013 WP final reports for JA1 and AP financial statements October December development of the JA2 3-year Work Plan WP1 meeting in Copenhagen in January 2013 March 2012 Plenary Assembly meeting (endorsement of the 3-year Work Plan) HOWEVER, October 2012 JA2 WP4 and WP5 should have a project description in place (WP5 milestone M3; WP4 milestone M8) October-December putting the new JA2 information platform in place January new JA2 web platform goes live! 11

23 EUnetHTA and permanent European network on HTA a. Commission and MS updates on current developments re: Article 15 implementation b. Levels of involvement c. Membership issues d. Stakeholder relations/involvement 12

24 EUnetHTA and permanent European network on HTA Article 15 implementation timeline February-May: Feasibility study to provide estimates on running costs for different management models February-June: Country visits to selected Ministries of health. Purpose: to map the willingness of key HTA countries to engage in an ambitious approach April: Informal Council with discussion session on HTA May: Pre-discussion with EUnetHTA on the draft Commission Decision at the Plenary Assembly June July: Stakeholder Consultation on the HTA network November: Initial Committee Discussion on the HTA network 13

25 EUnetHTA and permanent European network on HTA Article 15 implementation timeline February-March: Formal Committee Discussion March-May: Inter-service Consultation on draft implementing act May-June: Voting in the Committee on the draft implementing act June-September: Written procedure and adoption of implementing act 14

26 EUnetHTA and permanent European network on HTA Article 15 implementation Qs to the Commission: - Legal framework re: establishing a legal entity (eg, to handle IPR issues) - Financing rules/limitations/views on financing approaches/income streams for the permanent network and its Secretariat 15

27 Levels of involvement EUnetHTA Strategy Commission Basic level (sharing reports) EUnetHTA Strategy document (p.2): Committed level (information and methods are shared within the agreed EUnetHTA framework/using EUnetHTA tools) Advanced level (common standards and tools are used in collaborative HTA projects) Level 1: Focus on sharing and exchange of HTA information Level 2: Development of common generic guidelines for HTA Level 3: Enable the use of the guidelines at national level for easier sharing of HTA information Level 4: Coordinated/joint HTA processes with reuse of HTA information at national level 16

28 Levels of involvement - Common understanding of what is behind each level - Try to harmonise between the two sets - Minimum requirements for involvement - Minimum requirements on agreeing for common processes in the network 17

29 Levels of involvement - new European network for HTA levels of involvement Level 1 (entry level): Sharing and exchange of information and methods (within the agreed EUnetHTA framework) Level 2: Development of common generic guidelines for HTA Piloting standardisation of the guidelines use at the national level (within defined time and access to resources supporting such piloting; reporting on the experience) Level 3: Application of common standards and tools in collaborative HTA projects with re-use of HTA information at national level 18

30 Membership issues - Regional agencies - EUnetHTA Collaboration Founding Partners - Number of partners per MS (relevance to Governance issues) - Orgs that are not nominated but interested to participate - Associates status (on which premises are given?) and their role and contribution mode - How to handle independence and conflict of interest issues with non-for-profits that have the private sector financing - Role of national networks 19

31 Stakeholder relations/involvement - Stakeholder Forum composition in JA2 - Stakeholder Forum role beyond JA2 (link to governance issues) - Types of involvement to be considered (post-ja2) - Current governance structure - Business model considerations - Other? 20

32 Agenda April 19 21

33 Governance, management and accountability PA: partners or MS representation? Voting rights Exec Comm: composition alternatives SF: free standing? Managed in connection to the Exec Comm or Plenary Assembly? Coordination: central and distributed? Activity centers (aka WPs )?Project management who is responsible for what EUnetHTA products who and how is responsible for, eg, quality assurance, management of potential legal disputes What are the EUnetHTA products only tools? Or Core HTA information as well? Role of the Commission in the future network Will EUnetHTA have a one voice for.. ie, expressing of common position on certain issues? Legal entity issue who is to, eg, hold the IPRs, be legally responsible, collect fees/financing for the network activities 22

34 Coordination secretariat Stakehold er forum Article 15 network Network assembly MS plus SANCO P&A forum Executive committee ACTI VITY ACTI VITY ACTI VITY ACTI VITY SAG SAG SAG SAG 23

35 Financing streams Commission: MS: - What types of activities? Priorities? Who can receive funding for what for, eg training attendance? For, managing Core HTA information production? - Magnitude and form of contribution? How to connect to the level of involvement and define minimum financing required? 24

36 Financing streams Other income sources: - Fee for services (see Business model)? - Licensing fees? - Membership fees for those orgs that are not nominated by the MS? - Any limitations on receiving fees for the permanent network s Secretariat (Commission s rules)? 25

37 Working with EU bodies and international orgs Issue for JA2 as well as for the permanent network: - Which EU bodies? How to prioritise? - Which unit in the governance structure will be the reference point for engagement with the EU bodies? - Which international orgs? What type of engagement? - Working together on certain projects, regular contribution during certain activities of such organisations, strategic aliances; which ones to prioritise RESOURCE CONSIDERATIONS (STAFF and TIME) 26

38 Working with EU bodies and international orgs Latest developments in device regulation in Europe how to handle in JA2? 27

39 Finalising the EUnetHTA strategy development and moving to implementation a) Final endorsement in Lisbon b) Taking it into the work of JA2 WP1 (as a part of the 3-year Work Plan) 28

40 EUnetHTA Plenary Assembly Lisbon, May Agenda Nomination process Practicalities 29

41 Draft Agenda A final agenda and info pack will be shared on May 9, Key figures and main achievements of EUnetHTA (short orientation) 2. Discussion about Work Package activities during 2011 (background information will be sent in advance) 3. Election process of the 3 members in the Executive Committee, PA chair and deputy chair 4. WP3 NETSCC evaluation based on survey 5. Collaboration with other networks/organisations: EMA; INAHTA; TAPESTRY and others 6. Ways to enhance the communication with Stakeholder Forum (SF) 7. Procedural matters re: governing principles (including SF policy and operational procedures) 8. Financial information and grant guidelines (end of JA1 and plans for JA2) 30

42 Draft Agenda 9. Ways to increase Implementation of the EUnetHTA tools in MS Feedback system to measure efficiency and implementation of EUnetHTA tools in Member States Facilitation of use / integration of core HTA information Information Management System (New Websites) 10. EUnetHTA strategy: discussion and endorsement 11. EUnetHTA Business Model, future implementation and stages until full operation 12. Secretariat role and duties during JA2 and the permanent network 13. Future Article 15 HTA network with regards to the EUnetHTA Strategy and BM Commission s Article 15 implementation process update (ECORYS analysis) Stakeholder involvement based on the executions 31

43 Nomination process and elections Nomination process follows the EUnetHTA Collaboration Organisational Structure Governance Guiding Principles t pdf The election process is based on the view that JA1 and JA2 are a continuation of the same network/project, going through different phases. The guidance on the partners eligibility for elections follows this approach 32

44 A. Gemelli SDU A Diagram to illustrate the distribution of Partners on EUnetHTA Collaboration Founding Partners, EUnetHTA Joint Action Partners and EUnetHTA Joint Action 2 Partners UETS EUnetHTA Collaboration Founding Partners SNHTA AVALIA-t IQWIG AHTAPol HAS EUnetHTA Joint Action Associated Partners DIMDI NOKC VASPVT Agenas THL MoH Spain AETSA ISCIII OSTEBA LBI-HTA CVZ Reg Veneto CAHIAQ ASSR NBoH SBU NICE NETSCC KCE HVB UTARTU INFARMED EUnetHTA JA 2 Associated Partners SSD/MHEC GYEMSZI NSPH MoH Cz AIFA GÖG AQAHC, Cr NCPHA, Bu NIPH VEC HIQA Cyprus HTA&HSR, DK FIMEA IER 33

45 Nomination and election process and elections Information regarding the nomination was sent twice to all partners and is available on the MO website The elections will take place during the first PA day, (May 24, 2012) Election for 3 electable seats in the Exec Comm (for organisations): one year position Election for PA chair/ Deputy Chair (for individuals): two years positions

46 List of nominees: Plenary Assembly Chair: Mirjana Huic Plenary Assembly co-chair: Plenary Assembly 3 seats in Exec Comm: AHTAPol 35

47 Practicalities Max no. of participants: 65 SF participation: 4 EU Commission participation: 1(2?) Hosting organisation: INFARMED Location: INFARMED, Parque da Saude de Lisboa, Av. Do Brasil, 53, Lisboa Accommodation: 4 options in MO-calendar Social event: guided tour of Lisbon followed by a dinner All relevant information is available on the MO. A full info pack will be available in the PA area by May 9,

48 Update on registration Current registrations (April 16 deadline): 29 partners (67%) reminder was sent April 17 1 Commission rep (DG Sanco) 1 Rep from SF (payers) 10 orgs asking for the second participant to attend Total: 50 persons (with 2nd attendant included) ECORYS was invited to present the results of their costbenefit study 37

49 Other issues and conclusion a) EUnetHTA at HTAi b) EUnetHTA information platform development (JA and JA2) c) JA budget reallocation update d) CIRS interviews on benefit/risk assessment 38

50 WP1 Appendix 2 for Appendix 1

51 WP1 Executive Committee Rome, April 18th-19th 2012 WP4 Strand A Update FINOHTA/THL EUnetHTA Joint Action

52 WP4 Strand A Update (1) Online Tool and Service Basic functions ok for the two pilot core HTAs Advanced functions, including better project scoping, under construction. Pilot testing delayed from M23 to M27/M29. Concept paper 2nd version under review in OTS WG Screening Model 2nd public draft ready. Lots of feedback and suggestions for improvement gathered. Final version Dec Policies Survey results analyzed, soon to review within WP4, then SAG and public consultation. Delayed, process simplified to meet project timeline. 2

53 WP1 Executive Committee Rome, April 18th-19th 2012 WP4 Strand B Update Agenas EUnetHTA Joint Action

54 WP4 Strand B Update (1) Two surveys to obtain more information on the technologies of the two core HTAs have been conducted. Following the low response rate, both surveys were sent again to EUnetHTA Partner with new deadlines. Further information has been sought from the manufacturers of 3 genetic tests for breast cancer; the (disappointing) answers were received and shared among Domain Teams 4

55 WP4 Strand B Update (2) Core HTA 1 (Genetic Tests for BC) has completed first drafts from the following domains: TEC (Description and technical characteristics of technology) SAF (Safety) EFF (Clinical effectiveness) ORG (Organizational aspects) Core HTA 2 (AAA Screening): has completed first drafts from all domains; second draft is in progress. A Workshop in Wien took place on March 29-30: discussion on protocol drafts, domain drafts and Validation of Core HTAs Recruitment of new reviewers: a message for all EUnetHTA partners for availability of new reviewers in some Domains is being written. 5

56 WP1 Appendix 3 for Appendix 1

57 REA of Pharmaceuticals (JA1 WP5) Methodology guidelines and EPAR review Mira Pavlovic April 18, 2012 EUnetHTA Joint Action

58 Update on activities WP5: SG4 Ongoing actions 3rd drafts received by all authors 1st batch: (5 March 2012) Clinical endpoints Composite endpoints Surrogate endpoints Choice of comparator Direct and indirect comparisons 2 nd batch: (16 April 2012) HRQoL Safety Internal validity Applicablity 2

59 Update on activities WP5: SG4 Ongoing actions Guidelines WP5 and SAG consultation EMA and Public consultation Clinical EP Composite EP Surrogate EP Choice of comparator Direct and indirect comparisons HRQoL Safety Internal validity Applicablity March 7- April 13 All comments received and sent to the authors on April 18 Revised versions expected by May 7 Just started: May 14 July 14 April 17 May 25 June 29 Sept. 14 3

60 EPAR improvement project Parallel Review EPARs subject to the review: Pumarix, Esbriet, Teysuno, Xeplion, Xiapex, Gilenya, Halaven, Jevtana, Pravafenix, Trobalt EUnetHTA Each EPAR was reviewed by two HTA organisations from the EUnetHTA network Participating 10 HTA organisations were AETSA, AIFA, CAHIAQ, CMPT, CVZ, NICE, NOKC, HAS, HVB, UVT EMA First review of all EPARs performed by a single reviewer (not responsible for the writing of any of the reports) Subsequently a peer review was performed through a senior member of staff Same questionnaire Same assessment scales Same evaluation tool 4 4

61 EPAR improvement project Parallel Review 4 th EMA - EUnetHTA meeting (HAS, Paris): 22 Feb. 2012: presentation of the outcome of the parallel EPAR review Future actions: EUnetHTA (coordinated by HAS) to make a consolidated proposal for further improvements of the EPAR, highlighting expectations New EUnetHTA EMA face-to face meeting to solve the remaining issues The EMA-EUnetHTA parallel EPAR review will be presented to the CHMP and published (in Value in Health) 5 5

62 WP1 Appendix 4 for Appendix 1

63 Executive committee face to face meeting WP6 Progress report Patrice Chalon , Rome, Italy EUnetHTA Joint Action

64 WP6 overview Meetings Surveys Communicat ion Members only site Single sign on Planned and ongoing projetcs database 2012 M25 M26 M27 M28 M29 M30 M31 M32 M33 M34 M35 M36 Developmen t and testing 1st emeeting ftf meeting preparation 4th ftf 2nd e- meeting Survey 2 preparation Survey 2 Survey 2 analysis Contact database updated Development and testing Communication on regular basis site update Support to adaptation of information about policy 2nd release HTA reports & supplement al materal Information about policy decisions collaboration w ith existing tool (outside EUnetHTA) is evaluated vs development of specific new tool collaboration w ith existing solutions (outside EUnetHTA) is evaluated Development and testing Report and w orkflow delivered Tool released Tools supporting day to day collaboratio n JA2 w ebsites Training and support Development and testing Mailing list server released Development, testing and provision of learning material User support Evaluation and final report Evaluation and preparation of WP final technical report WP Final technical report

65 Details Task Comment 2 nd survey Was delayed due to sick leave, now started Contact db Hold on due to possible change of infrastructure POP db release 2 Started, release delayed to 3 rd quarter 2012 Documents db Information policy decisions Mailing list JA2 Websites Started Evaluation started, see JA2 WP2 Community of Practice No started yet See below 3

66 JA2 Websites: Project description Tasks achieved Description Surveys and interviews Requirements synthesised Analysis of requirements Technical options identified for Website and Intranet / workrooms / project management + basic tests Preliminary contacts with potential furnishers (technical information) Tasks to do Meeting task force (planned Apr. 26) Preparation European tender Planning May: tender June-July: selection provider Oct: Start implementation 01/01/2013: Live 4

67 JA2 Websites: participants KCE Secretariat Gudrun Briat, Patrice Chalon, Carl Devos, Kirsten Holdt Henningsen Julia Chamova, Naomi Dayan, Inge Merete Skov Task Force Susanne Eksell, Gottfried Endel, Judit Erdos, Eleanor Gueguan, Wim Goettsch, Sarah Kleijnen, Leena Raustia, Ingvil Sæterdal, Sorin Stanel, Claudia Wild, 5

68 WP1 Appendix 5 for Appendix 1

69 WP 7 New Technologies Update on Strand A Activities Mira PAVLOVIC (HAS, France) EUnetHTA Joint Action

70 WP 7 Objectives Strand A Facilitating evidence generation on new HT - criteria to select new technologies in need of further evidence - minimum dataset to share information on policy relevant clinical studies in development - database (EIFFEL) to share information & facilitate collaboration on additional evidence generation Strand B Facilitating exchages on current HT assessments - information flow on HT assessments & alerts on parallel HTA projects - collaboration on HTA projects - Database (POP) to provide updated information on planned and ongoing HTA projects 2

71 Achieved WP7A Milestones October April 2012 Selection criteria: Testing of criteria by WP 7 partners (17 responses received, analysis ongoing): 2-month delay, to be delivered end of April EVIDENT database: Additional survey further clarification on EVIDENT among WP7 partners (clarification of issues regarding database s characteristics): done Public consultation (15 responses database s content adjusted): done IT implementation: since March 2012 All milestones finalized on time, only testing of criteria slightly delayed 3

72 Next steps according to the Work plan Selection criteria: Public consultation on the final version: May 2012 Publication of the final version: June 2012 (2 nd WP 7 deliverable) EVIDENT Database: Operational database launch: September 2012 (3 rd WP 7 deliverable) Next FtF meeting: May 10th-11th, Vienna (validation of deliverables) 4

73 WP1 Appendix 6 for Appendix 1

74 WP 7B New Technologies POP database Claudia Wild, Judit Erdös, Marisa Warmuth LBI-HTA, Austria WP 1 face-to-face meeting 18/19 April 2012, Rome/Italy EUnetHTA Joint Action

75 Milestones 2012 M25 M26 M27 M28 M29 M30 M31 M32 M33 M34 M35 M36 FTF Meetings Meeting preparation 4th ftf meeting Vienna POP database development (in coop. with WP 6) Development and testing database version 2 POP db 2nd release Database is routine & regularly used by EUnetHTA partners POP request (reminder) 8th request 9th request 10th request 11th request POP communication protocols 8th protocol 9th protocol 10th protocol 11th protocol Analysis of all communication protocols External analysis of all protocols Analysis report Coordination of collaborations on new high techs (active brokering) Coordination of collaboraton (at least 1 per year) Final report Preparation of final financial and technical report WP7 (B) Final report provided to WP 1

76 POP Statistics Currently the POP database contains: 1104 planned, ongoing and recently published projects from 41 EUnetHTA JA partners from 23 countries 7th (Nov/Dec 2011) Out of 62 EUnetHTA JA partners: 40 responded and entered projects into the database 2 responded but DID NOT feed the database 20 did not respond at all (32%) Total number of projects: 968 Alert topics: 83 Similar projects (within alert topics): 219 8th (Febr/March 2012) Out of 63 EUnteHTA JA partners: 40 responded and entered projects into the database 4 responded but DID NOT feed the database 19 did not respond at all (30%) Total number of projects: 1126 Alert topics: 120 Similar projects (within alert topics): 320

77 Challenges Passivity (both in response and in collaboration) Priorisation of the requirements in db development according to resources (staff, time) Access control of participating partners Contact fails: due to turnover at partner agencies no contact person afterwards Agencies with VERY MANY projects: NETSCC + NICE (50% of db projects!) continue sending Excel lists 2 step work for LBI- HTA: 1st: to sort out their projects 2nd: to add MeSH terms

78 Future perspectives JA 2 : POP maintenance, co-operation Goal: partners update regularly w/o reminder s from LBI-HTA

79 Thank you.

80 WP1 Appendix 7 for Appendix 1

81 Establishing the HTA network: key issues

82 Presentation outline Directive provisions Overall architecture and adoption process Issues at stake Scope of work Goverance of the network Link with EUnetHTA

83 Commission objectives on HTA Reduce duplication of work for MS. Cost/ efficiency gains Reduce national hurdles to market access faced after licensing Promote the early dialogue (scientific advice) between sponsors and HTA bodies/ payers during the HT. development process All health technologies to be covered, but particular action needed for pharmaceuticals and MD Support MS + stakeholders with little HTA capacity

84 Article 15, Directive patients rights in cross border care From project-based to permanent cooperation on HTA The objectives of the HTA network shall be to: support cooperation between national authorities or bodies; support Member States in the provision of objective, reliable, timely, transparent, comparable and transferable information on the relative efficacy as well as on the shortand long-term effectiveness when applicable, of health technologies and to enable an effective exchange of this information between the national authorities or bodies. support the analysis of the nature and type of information that can be exchanged; avoid duplications of assessments. 4

85 Setting up the HTA Network Creation of The Committee on cross-border healthcare Implementing committee - examination procedure Launch meeting: 21 June 2011 Draft Implementing act (under the form of a COM Decision) on: 1) Measures for the establishment, the management and the transparent functioning of the HTA network 2) Arrangements for granting the aid, the conditions to which it may be subject and the amount of the aid Discussion in the Committee of the draft Implementing act Vote in the Committee (QMV in favour), after Commission inter-services consultation Adoption by COM = HTA Network set up (max Oct. 2013) Adoption of the rules of procedures by the Network

86 Governance level Possible governance structure Network assembly (EU27 + EFTA/EEA3 + CR(?)(1 nominated/ country) Work programme, supervision, adoption of recommendations/conclusions Stakeholder forum Executive committee (elected by the Network assembly) Oversees activities initiated in the network Production level Cluster of HTA agencies (May include regional HTA ag.) Secretariat Coordination Etc. Coordination with EMA, CIE etc. Etc. EUNETHTA brand name? Stakeholder advisory groups

87 Issue at stake: formalising the network HTA agencies still in a phase of trust-building To what extent should the rules of procedures formalise the governance issues? Need to find a balance between bringing clarity to MS without blocking the capacity building process Possible solution: Agree on general principles in 2013, with agreement on review rules of procedure following the end of JA2?

88 Issue at stake: scope of the work The network should allow for different levels of involvement from participating organisations. Our suggestion is that four such levels are defined, e.g.: Level 1: Focus on sharing and exchange of HTA information Level 2: Development of common generic guidelines for HTA Level 3: Enable the use of the guidelines at national level for easier sharing of HTA information Level 4: Coordinated/joint HTA processes with reuse of HTA information at national level MS should reflect on how they see this in the context of their national HTA work

89 Issue at stake: the Network 1. Membership: voluntary HTA bodies designated by member States (MS), but: Can MS appoint an unlimited number of HTA bodies? What to do with regional HTA organisations? Will we see members with various status at national level (public, independent etc.)? How should stakeholders be involved? 2. Decision making process: Will be fixed through the Network rules of procedures : chairing, voting but: What if a MS was not involved in the activity in question? How to endorse deliverables from the network?

90 Issues at stake: Eunethta Decision making process: Link between the Network and Eunetha Governance of Eunetha: Members of the plenary assembly, executive committee, stakeholders forum. Status of regional agencies? Adoption of the work program and deliverables, appointments of rapporteurs Hosting of the secretariat Formalising interaction with other bodies: Clinical investigation and evaluation, EMA, ECDC, JRC

91 Issues at stake: Eunetha Financing of the network: Until end 2015: Joint Action 2 on HTA will finance all major activities Post 2015: To be supported by the Health for Growth program + RTD funds? EU financing to support learning curve of the cooperation process How to finance early dialogue/scientific advice? Capacities Multi sectoral expertise needed

92 Timeline 8 Dec 2011: Kick-off for discussion in Gdansk Spring 2012: External feasibility study on cost benefit analysis of various scenarios + consultation with stakeholders on modalities for stakeholder consultation Autumn 2012: Draft Commission Decision development, to be discussed in the CBHC committee Winter/spring 2013: Discussions in the 2011/24/EU committee June/September 2013: Commission adopts the Commission Decision. From October 2013: MS nominations to network + discussion/ adoption of the rules of procedures 12

93 WP1 Appendix 8 for Appendix 1

94 Regulation of MD in Europe: time to changes? Marina Cerbo Roma, April 2012

95 Position paper Medical devices: an entire overhaul of the European authorisation and surveillance system* for high-risk Medical Devices is urgently needed (March 2012) *Dir. n. 93/42/CEE AIM (Association Internationale de la Mutualité) is a grouping of autonomous health insurance and social protection bodies operating according to the principles of solidarity and non-profit-making orientation; 25 countries; 160 million people. ESIP (European Social Insurance Platform) Is an alliance of over 40 statutory social security organisations in 15 EU Member States and Switzerland. ISDB (International Society of Drug Bulletins) Is a worldwide network of bulletins and journals on drugs and therapeutics that are financially and intellectually independent of pharmaceutical industry; 35 countries around the world. MiEF (Medicines in Europe Forum) It includes more than 70 member organizations representing patients groups, family and consumer bodies, social security systems, and health professionals; in 12 EU Member States.

96 Regulatory framework Legislation Based on the New Approach, rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s. The core legal framework consists of 3 directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.

97 Main suggestions Considering the serious safety problems with high-risk medical devices in Europe (e.g. defibrillators, hip implants, breast implants) we call for a new framework that focuses on strengthened transparency and patient safety: (1) Marketing Authorisation The establishment of an independent centralised authorisation system for high-risk medical devices and implants (the manufacturer should provide results of a positive benefit-harm balance for patients during clinical trials; study protocols and results need to be published in a centralised public accessible database/registry). (2) Surveillance and Vigilance A strong post-marketing surveillance system (unannounced inspections by authorities; notification of failures and public alerts; cooperation among public authorities; traceability and product recalls; unique identifier system combined with patient/medical devices registries; improved information for patients and health actors). (3) Reinforcement of Patient Rights and Liability Reinforcement of patients and third party payers rights (compensation right) in case of harm or damage.

98 WP1 Appendix 9 for Appendix 1

99 Executive committee face to face meeting JA2 Websites Patrice Chalon , Rome, Italy EUnetHTA Joint Action

100 WP6 overview Meetings Surveys Communicat ion Members only site Single sign on Planned and ongoing projetcs database 2012 M25 M26 M27 M28 M29 M30 M31 M32 M33 M34 M35 M36 Developmen t and testing 1st emeeting ftf meeting preparation 4th ftf 2nd e- meeting Survey 2 preparation Survey 2 Survey 2 analysis Contact database updated Development and testing Communication on regular basis site update Support to adaptation of information about policy 2nd release HTA reports & supplement al materal Information about policy decisions collaboration w ith existing tool (outside EUnetHTA) is evaluated vs development of specific new tool collaboration w ith existing solutions (outside EUnetHTA) is evaluated Development and testing Report and w orkflow delivered Tool released Tools supporting day to day collaboratio n JA2 w ebsites Training and support Development and testing Mailing list server released Development, testing and provision of learning material User support Evaluation and final report Evaluation and preparation of WP final technical report WP Final technical report

101 JA2 Websites: Project description Tasks achieved Description Surveys and interviews Requirements synthesised Analysis of requirements Technical options identified for Website and Intranet / workrooms / project management + basic tests Preliminary contacts with potential furnishers (technical information) Tasks to do Meeting task force (planned Apr. 26) Preparation European tender Planning May: tender June-July: selection provider Oct: Start implementation 01/01/2013: Live 3

102 Surveys & interviews 4

103 Public site Provide general EunetHTA information 5

104 Intranet Information and documents to AP Support project management Support communication among partners Provide sense of unity 6

105 Work rooms Support group work Support processes Support sharing of group material Support of confidentiality 7

106 Analysis Overlap Public site & intranet Overlap intranet & workrooms More information for public site

107 Task force APRIL 26 DMS CMS LMS? 9